BS EN ISO 22610-2007 Surgical drapes gowns and clean air suits used as medical devices for patients clinical staff and equipment - Test method to determine the resistance to wet ba.pdf

1、 g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g40g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58patients, clinical staff and equipment Test method to determine the resistance to wet bacterial pen

2、etrationThe European Standard EN ISO 22610:2006 has the status of a British StandardICS 13.340.10Surgical drapes, gowns and clean air suits, used as medical devices, for BRITISH STANDARDBS EN ISO 22610:2006BS EN ISO 22610:2006This British Standard was published under the authority of the Standards P

3、olicy and Strategy Committee on 31 January 2007 BSI 2007ISBN 978 0 580 50106 7Amendments issued since publicationAmd. No. Date CommentsThis publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application.Compliance with a British

4、Standard cannot confer immunity from legal obligations.National forewordThis British Standard was published by BSI. It is the UK implementation of EN ISO 22610:2006.The UK participation in its preparation was entrusted by Technical Committee CH/205, Non-active medical devices, to Subcommittee CH/205

5、/1, Medical textiles.A list of organizations represented on CH/205/1 can be obtained on request to its secretary.EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 22610July 2006ICS 13.340.10English VersionSurgical drapes, gowns and clean air suits, used as medicaldevices, for patients, clinical

6、staff and equipment - Test methodto determine the resistance to wet bacterial penetration (ISO22610:2006)Champs chirurgicaux, casaques et tenues de bloc, utilissen tant que dispositifs mdicaux, pour les patients, lepersonnel et les quipements - Mthode dessai dersistance la pntration de la barrire ba

7、ctrienne ltat humide (ISO 22610:2006)Operationsabdecktcher, -mntel und Rein-Luft-Kleidung,zur Verwendung als Medizinprodukte, fr Patienten,Klinikpersonal und Gerte - Prfverfahren fr dieWiderstandsfhigkeit gegen Keimdurchtritt im feuchtenZustand (ISO 22610:2006)This European Standard was approved by

8、CEN on 24 May 2006.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may

9、 be obtained on application to the Central Secretariat or to any CEN member.This European Standard exists in three official versions (English, French, German). A version in any other language made by translationunder the responsibility of a CEN member into its own language and notified to the Centra

10、l Secretariat has the same status as the officialversions.CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,

11、 Portugal, Romania,Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: rue de Stassart, 36 B-1050 Brussels 2006 CEN All rights of exploitation in any form and by any mea

12、ns reservedworldwide for CEN national Members.Ref. No. EN ISO 22610:2006: EForeword the latest by January 2007. This document has been prepared under a mandate given to CEN by the European Commission and the According to the CEN/CENELEC Internal Regulations, the national standards organizations of t

13、he followingDenmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden,Switzerland and United Kingdom. This document (EN ISO 22610:2006) has been prepared

14、 by Technical Committee CEN/TC 205 “Non-active medical devices“, the secretariat of which is held by DIN, in collaboration with Technical Committee ISO/TC 94 “Personal safety - Protective clothing and equipment“. text or by endorsement, at the latest by January 2007, and conflicting national standar

15、ds shall be withdrawn atEuropean Free Trade Association, and supports essential requirements of EU Directive(s). For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document.countries are bound to implement this European Standard: Austria, Belgium, Cypr

16、us, Czech Republic, This European Standard shall be given the status of a national standard, either by publication of an identicalEN ISO 22610:2006Reference numberISO 22610:2006(E)INTERNATIONAL STANDARD ISO22610First edition2006-07-01Surgical drapes, gowns and clean air suits, used as medical device

17、s, for patients, clinical staff and equipment Test method to determine the resistance to wet bacterial penetration Champs chirurgicaux, casaques et tenues de bloc, utiliss en tant que dispositifs mdicaux, pour les patients, le personnel et les quipements Mthode dessai de rsistance la pntration de la

18、 barrire bactrienne ltat humide EN ISO 22610:2006ii iiiContents Page Foreword iv Introduction v 1 Scope . 1 2 Normative references . 1 3 Terms and definitions. 1 4 Principle. 2 5 Reagents and materials 3 6 Apparatus 3 7 Preparation of test samples and pieces. 3 7.1 Agar plates 3 7.2 Carrier material

19、 . 4 7.3 Test specimen . 4 8 Procedure 4 8.1 Preparation of donor 4 8.2 Conditioning 4 8.3 Test set-up. 4 8.4 Application of materials . 4 8.5 Test. 5 9 Test report . 5 10 Performance monitoring 6 10.1 General. 6 10.2 With carbon paper 6 10.3 With reference material 6 Annex A (normative) Apparatus f

20、or testing resistance to wet bacterial penetration 7 Annex B (normative) Nutrient media 10 Annex C (informative) Examples of how to use the test results to characterize a barrier material 12 Bibliography . 14 Annex ZA (informative) Relationship between this European Standard and the Essential Requir

21、ements of EU Directive 93/42/EEC . 15 EN ISO 22610:2006iv Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committe

22、es. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the Inte

23、rnational Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International S

24、tandards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this document may be the su

25、bject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 22610 was prepared by the European Committee for Standardization (CEN) Technical Committee CEN/TC 205, Non-active medical devices, in collaboration with Technical Committee ISO/TC 94, Persona

26、l safety Protective clothing and equipment, Subcommittee SC 13, Protective clothing, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement). EN ISO 22610:2006vIntroduction There are numerous examples of situations where bacteria carried by a liquid may migra

27、te through a barrier material in the wet state. The wet penetration of skin flora through a covering material is one example. European Medical Device regulations specifically place the responsibility for avoiding device-related infections on the manufacturer. In order to demonstrate compliance with

28、this requirement and to describe a product to the user, there is a need to use harmonized and recognized international test methods. The test method described in this international standard uses microbiological techniques and is therefore intended to be performed exclusively by laboratories experien

29、ced in and equipped for such work. EN ISO 22610:2006blank1Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment Test method to determine the resistance to wet bacterial penetration WARNING The use of this standard may involve hazardous materi

30、als, operations and equipment. This standard does not purport to address all of the safety problems associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and to determine the applicability of regulatory limitations prior t

31、o use. 1 Scope This International Standard specifies a test method, with associated test apparatus (see Annex A), which is used to determine the resistance of a material to the penetration of bacteria, carried by a liquid, when subjected to mechanical rubbing. 2 Normative references The following re

32、ferenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 139, Textiles Standard atmospheres for conditioning and testi

33、ng ISO 6330, Textiles Domestic washing and drying procedures for textile testing ISO 11607, Packaging for terminally sterilized medical devices ISO 13485, Medical devices Quality management systems Requirements for regulatory purposes ISO 13683, Sterilization of health care products Requirements for

34、 validation and routine control of moist heat sterilization in health care facilities ISO 13934-1, Textiles Tensile properties of fabrics Part 1: Determination of maximum force and elongation at maximum force using the strip method ISO 13937-2, Textiles Tear properties of fabrics Part 2: Determinati

35、on of tear force of trouser-shaped test specimens (Single tear method) ISO 15797, Textiles Industrial washing and finishing procedures for testing of workwear EN 554, Sterilization of medical devices Validation and routine control of sterilization by moist heat 3 Terms and definitions For the purpos

36、es of this document, the following terms and definitions apply. 3.1 agar plate Petri dish containing sterile nutrient agar medium NOTE See Annex B for composition of nutrient media. EN ISO 22610:20062 3.2 carrier material material used to prepare the donor 3.3 covering material material, e.g. surgic

37、al drapes, used for covering the patient, equipment and certain surfaces to prevent the patients skin bacteria and/or bacteria from other non-sterile sources from reaching the operation wound 3.4 donor material that has been contaminated with a known number of viable cells of a defined strain of tes

38、t bacterium 3.5 finger part of the apparatus for testing resistance to wet bacterial penetration, used to bring donor and test specimen into contact with the surface of an agar plate 3.6 replicate test one complete evaluation of a single test piece, from the test specimen, comprising five plate coun

39、ts directly against the donor and a sixth plate to estimate the residual bacterial challenge on the reverse of the test piece 3.7 test material piece of covering material, 25 cm 25 cm, for which the resistance to wet bacterial penetration is being determined 3.8 reference material standardized mater

40、ial to assess the precision of the laboratory when performing the test for resistance to wet bacterial penetration 3.9 resistance to wet bacterial penetration the resistance of a barrier to the penetration of bacteria, carried by a liquid, when subjected to mechanical rubbing 4 Principle A test spec

41、imen is placed on an agar plate. A sheet of donor material, of corresponding size and carrying the bacteria, is placed on the test specimen with the contaminated side face down and covered by a sheet of approximately 10 m high density polyethylene (HDPE) film. Two tithing conical steel rings hold th

42、e three sheets together, applying a tensile force. An abrasion-resistant finger is placed on top of the materials with a specified force to bring the test specimen in contact with the agar. The finger is moved over the entire surface of the plate in less than 15 min by means of a pivoted lever moved

43、 by an exocentric cam. The assemblage of materials, stretched by the weight of the steel rings, ensures that only a small area of the test specimen is brought into contact with the agar surface at any one time. Due to the combined effect of rubbing and liquid migration, bacteria may pass from the do

44、nor material through the test specimen down to the agar surface. After being tested for 15 min, the agar plate is replaced by a fresh one, and the test is repeated with the same donor and test specimen. Allowing 15 min for each test, five tests are performed with the same pair of donor and test spec

45、imen. In this way, the test allows for an estimation of the penetration over time. Finally, the bacterial contamination on the top side of the test specimen is estimated using the same technique. The agar plates are incubated in order to observe the bacterial colonies, which are then enumerated. The

46、 results may be processed in accumulated form in order to characterize the barrier capability and penetration over time of the material (see Annex C). EN ISO 22610:200635 Reagents and materials 1)5.1 5 sets of 6 agar plates, 14 cm diameter, filled with nutrient agar (see B.4 and 7.1). 5.2 Five piece

47、s of carrier material, 25 cm 25 cm, to produce donors (see 7.2). 5.3 Five pieces of HDPE film, 25 cm 25 cm, or with a diameter of 25 cm, of approximate thickness 10 m, for use as finger covers. The HDPE film shall have a density of (950 2) kg/m3and a mass flow rate (190 C, 5 kg) of 0,027 g/min. 5.4

48、Staphylococcus aureus ATCC 29213 strain. 5.5 Five test specimens, 25 cm 25 cm (see 7.3). 5.6 Reference material (for use in 10.3) comprising a 135 g/m2microfilament polyester fabric, washed three times in accordance with an appropriate wash process in ISO 6330 or ISO 15797. 6 Apparatus 6.1 Cylindric

49、al body, approximately 9 cm in diameter and 4 cm in height. 6.2 Apparatus, as shown in Annex A. The apparatus has an electrically-driven, timer-controlled turntable which holds a 14 cm diameter agar plate. A horizontal lever with a vertical finger at its end is fitted to a pivot, allowing sideways movements of the finger from the centre to the periphery and back of the rotatable (60 r/min) agar plate. A weight can be slid along the lever to adjust the force exer